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1+ months

Senior Process Development Engineer

Medtronic
Danvers, MA 01923
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Senior Process Development Engineer

Location:

Danvers 35 Cherry Hill, Massachusetts, United States

Requisition #:

21000VFF

Post Date:

Dec 12, 2021


**Careers That Change Lives**


In this exciting role as a senior engineer, you will have responsibility for developing catheter extrusion and other related processes . The Danvers Extrusion center of excellence is one of the largest polymer processing plants in the medical device industry with over 30 active extrusion lines. Medtronic helps patients all over the globe to alleviate pain, restore health, and extend life. This role reports to the product development manager and oversees and directs the work of a team of engineers working on next generation heart valve delivery catheter systems. This role will also help develop new extrusion technologies.


**A Day in the Life**


Responsibilities may include the following and other duties may be assigned.


+ Proven track record of hands-on extrusion expertise in developing new extrusion process from ground up.

+ Provides technical and sustaining engineering support in a manufacturing area.

+ Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products.

+ Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.

+ Reviews product development requirements for compatibility with processing methods to determine costs and schedules.

+ Interacts with product design and development personnel to ensure that processes and designs are compatible.

+ May develop and conduct statistical analysis or recommend additions to document work.

+ Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.

+ This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.

+ Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.

+ Ensures processes and procedures are in compliance with regulations.


**Must Have: Minimum Requirements**


+ Bachelors degree required

+ Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience


**Nice to Have**

Preferred hands-on-experience in extrusion process development with 8+ years of experience


This is a Flexible position, people with higher experience level are welcome to apply to this position and will be well compensated / positioned accordingly.


Develop/mentor extrusion engineering talent pipeline with hands on experience.


Proven track record of extrusion expertise in developing any one or moreof the following process from ground up is preferred.


+ Multi-lumen extrusion

+ Free form extrusion

+ Vacuum forming extrusion

+ Shrink tubing

+ Intermittent / full A/B extrusion

+ Braided catheter extrusion

+ Extruded Coating

+ Multilayer co-extrusion

+ Bump tubing


Familiar with processing Pebax, Nylon derivates, polyurethane, engineering polymers


5+ years of experience in an extrusion manufacturing environment, preferably in a medical device setting.


Experience in process validations, statistics and SPC using Minitab software


Extensive knowledge of plastic chemistry and properties


Experience in transferring product from pilot to production


Proficient in designing, acquiring, and implementing new equipment and processes


Familiar with design controls, FDA regulation - ISO 13485, 21 CFR 820, and CGMP practices


Relies heavily on experience and judgment to plan and accomplish goals


Good working knowledge of GDT


Generate and conduct validations independently and assist technicians and engineers in executing validation protocols (IQ/PD/PC/OQ/PQ/TMV)


Design tooling to support new extruded products or process improvements


Lead and support a team of Engineers and Technicians


Initiate, direct, and support projects to implement innovative equipment processes, and methods that enhance efficiency, improve safety, and increase profitability


Hands-on role which requiring on-site support and managing other employees


Proven ability to take the lead role in extrusion engineering functions which includes validating and troubleshooting processes, identifying and implementing process improvements, managing projects, and expanding extrusion capabilities


**About Medtronic**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


Physical Job Requirements


The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2022-03-08 Expires: 2022-06-06
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Senior Process Development Engineer

Medtronic
Danvers, MA 01923

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